Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis (PSOR-003)

Amgen

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: CC-10004

Study type: Interventional

Funder types: Industry

Identifiers

NCT00606450

CC-10004-PSOR-003

Details and patient eligibility

About

There is an unmet medical need for safe, effective oral therapy for moderate-to-severe psoriasis. CC-10004 will be evaluated in a controlled setting of a clinical study. The information obtained from the study will aid in the design of future clinical trials and to establish the safety and efficacy of CC-10004.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must understand and voluntarily sign and informed consent form
• Must be in good health as judged by the investigator
• Must be able to adhere to the study visit schedule and other protocol requirements
• Must have greater than or equal to a 6 month history of moderate-to-severe plaque-type psoriasis
• Must have a Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and Body Surface Area (BSA) greater than or equal to 10%
• Must meet specific laboratory criteria
• Must be a candidate for photo/systemic therapy
• Women of childbearing potential must have a negative pregnancy test

Exclusion criteria

• Must not have clinically significant underlying disease processes
• Must not be pregnant or lactating females
• Must not have any condition, including lab abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study
• Must not have a history of active mycobacterium tuberculosis infection within 3 years prior to the screening visit
• Must not have a history of incompletely treated active of latent mycobacterium tuberculosis infection
• Must not have a know history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
• Must not be an immigrant form a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit
• Must not have current erythrodermic, guttate, or pustular psoriasis
• Must not have a clinical history of failure to adequately respond to treatment in the investigator's opinion to one or more treatment courses of cyclosporine or the following biologic therapies: alefacept, etanercept, efalizumab, infliximab or adalimumab
• Must not use topical therapy within 14 days of randomization
• Must not use systemic therapy for psoriasis within 28 days of randomization
• Must not use phototherapy within 28 days of randomization
• Must not use adalimumab or infliximab within 3 months of randomization
• Must not use etanercept or efalizumab within 56 days of randomization
• Must not use alefacept within 6 months of randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 3 patient groups, including a placebo group

20 mg Apremilast daily

Experimental group

Description:

20 mg of CC-10004 daily

Treatment:

Drug: CC-10004

Drug: CC-10004

20mg Apremilast twice daily

Experimental group

Description:

CC-10004 twice daily

Treatment:

Drug: CC-10004

Drug: CC-10004

Placebo

Placebo Comparator group

Description:

Placebo arm

Treatment:

Drug: Placebo